BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SULCARINGS

    K Number: K830116 · Decision Feb 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    165
    Registration Numbers
    165
    Same Product Code
    3
    Applicant Total
    11
    Review Days
    38

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    Basic Information

    Device Name
    SULCARINGS
    K Number
    K830116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    North Pacific Dental, Inc.
    Date Received
    January 11, 1983
    Decision Date
    February 18, 1983
    Product Code
    EIF
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EIF Accessories, Retractor, Dental

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    Other Clearances by North Pacific Dental, Inc.

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    K830105 VITATHYL
    K830114 GUTTA PERCHA POINTS
    K830107 SELFAST
    K830112 HYDROL
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